While large, prospective, blinded trials are the gold standard in clinical research, they require significant commitments of resources and time. Further, since these trials seek the answer to rather specific questions, the applicability and scalability of data obtained in these large trials is limited by the way in which it was collected. These trials will likely continue to be the final word in translational research, but in the face o contracting research budgets it is increasingly important to conduct only those studies that have a reasonable likelihood of answering the research hypotheses. Another reality of large, prospective clinical studies is that study designers must make a number of critical decisions (e.g., sample size) before the first data are collected. While statistical analyses exist to estimae sample size, they are often based on incomplete and sometimes insufficient preliminary information. Prior to embarking on an expensive prospective study, it would be particularly advantageous for investigators to have access to a large repository of high quality, codified, de- identified patient data. Given the recent ascension and recognized importance of patient reported outcomes (PRO) data in clinical trials, Dynamic Clinical Systems (DCS) is developing a research platform to open access to its large scale database of clinical PRO data. DCS will provide a unique and innovative solution that enables sustainable data collection and secure data access by opening its Web-based PRO system to researchers. This will provide researchers with access to de-identified PRO data broadly collected during routine care and in clinical studies. Further, DCS will boost the breadth and depth of its PRO data by integrating with complementary data sources and linking longitudinal patient-centric data. The result will be a continuously populating, secure PRO database available to researchers through a user-friendly interface. In Phase I we will 1) integrate our PRO database with a partner database to demonstrate feasibility and 2) create a prototype interface for research access. Feasibility will be established if the integration prototype seamlessly transfers data and passes tree test scenarios. We will test usability by querying clinical researchers as they use the interface prototype.

Public Health Relevance

Patient-reported outcomes (PRO) measured with sophisticated, yet easy-to-use assessments are a key way in which patients and study participants can communicate with their clinician or study coordinator, respectively. Dynamic Clinical Systems is developing an information technology solution that automates this process so that clinical trials are less expensive, require fewer numbers of participants, are less burdensome, and collect information about the patient's experience from the patient's perspective.

National Institute of Health (NIH)
National Library of Medicine (NLM)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-HDM-R (11))
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Ye, Jane
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Dynamic Clinical Systems, Inc.
United States
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